ID

31674

Descripción

Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00638690

Link

https://clinicaltrials.gov/show/NCT00638690

Palabras clave

Versiones (1)
  1. 19/9/18 19/9/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

19 de septiembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT00638690

Inglés

Eligibility Prostatic Neoplasms NCT00638690

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
metastatic castration-resistant prostate cancer progression after one or two prior cytotoxic chemotherapies
Descripción

Hormone refractory prostate cancer | Disease Progression metastatic | Status post Cytotoxic Chemotherapy Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1328504
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0677881
UMLS CUI [3,3]
C1265611
at least one chemotherapy must have contained docetaxel
Descripción

Chemotherapy Quantity Containing Docetaxel

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0246415
eastern cooperative oncology group (ecog) performance status <= 2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
medical or surgical castration with testosterone < 50 ng/dl
Descripción

Medical Castration | Male Castration | Testosterone measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513054
UMLS CUI [2]
C0007347
UMLS CUI [3]
C0523912
adequate bone marrow, hepatic and renal function
Descripción

Bone Marrow function | Liver function | Renal function

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
potassium >= 3.5 mmol/l
Descripción

Serum potassium measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0302353
able to swallow the study drug whole as a tablet
Descripción

Able to swallow Investigational New Drug Tablet

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0039225
informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than two prior cytotoxic chemotherapy regimens
Descripción

Cytotoxic Chemotherapy Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1265611
prior ketoconazole for prostate cancer
Descripción

Ketoconazole Prostate carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C0600139
prior abiraterone acetate or other cyp17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer
Descripción

Abiraterone acetate | CYP17 Inhibitor | Investigational New Drugs Targeting Androgen Receptor | Relationship Therapeutic procedure Prostate carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2607886
UMLS CUI [2]
C3160096
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C0034786
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0600139
uncontrolled hypertension
Descripción

Uncontrolled hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1868885
active or symptomatic viral hepatitis or chronic liver disease
Descripción

Viral hepatitis | Viral hepatitis Symptomatic | Chronic liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042721
UMLS CUI [2,1]
C0042721
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0341439
history of pituitary or adrenal dysfunction
Descripción

Pituitary dysfunction | Dysfunction adrenal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0281947
UMLS CUI [2]
C0549609
clinically significant heart disease
Descripción

Heart Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
other malignancy
Descripción

Cancer Other

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
known brain metastasis
Descripción

Metastatic malignant neoplasm to brain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
gi disorder affecting absorption
Descripción

Gastrointestinal Disease Affecting Absorption

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0237442
not willing to use contraception
Descripción

Contraceptive methods Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
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Similar models

Eligibility Prostatic Neoplasms NCT00638690

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Hormone refractory prostate cancer | Disease Progression metastatic | Status post Cytotoxic Chemotherapy Quantity
Item
metastatic castration-resistant prostate cancer progression after one or two prior cytotoxic chemotherapies
boolean
C1328504 (UMLS CUI [1])
C0242656 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0677881 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Chemotherapy Quantity Containing Docetaxel
Item
at least one chemotherapy must have contained docetaxel
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0246415 (UMLS CUI [1,4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status <= 2
boolean
C1520224 (UMLS CUI [1])
Medical Castration | Male Castration | Testosterone measurement
Item
medical or surgical castration with testosterone < 50 ng/dl
boolean
C1513054 (UMLS CUI [1])
C0007347 (UMLS CUI [2])
C0523912 (UMLS CUI [3])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, hepatic and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Serum potassium measurement
Item
potassium >= 3.5 mmol/l
boolean
C0302353 (UMLS CUI [1])
Able to swallow Investigational New Drug Tablet
Item
able to swallow the study drug whole as a tablet
boolean
C2712086 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cytotoxic Chemotherapy Quantity
Item
more than two prior cytotoxic chemotherapy regimens
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Ketoconazole Prostate carcinoma
Item
prior ketoconazole for prostate cancer
boolean
C0022625 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Abiraterone acetate | CYP17 Inhibitor | Investigational New Drugs Targeting Androgen Receptor | Relationship Therapeutic procedure Prostate carcinoma
Item
prior abiraterone acetate or other cyp17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer
boolean
C2607886 (UMLS CUI [1])
C3160096 (UMLS CUI [2])
C0013230 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0034786 (UMLS CUI [3,3])
C0439849 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0600139 (UMLS CUI [4,3])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Viral hepatitis | Viral hepatitis Symptomatic | Chronic liver disease
Item
active or symptomatic viral hepatitis or chronic liver disease
boolean
C0042721 (UMLS CUI [1])
C0042721 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0341439 (UMLS CUI [3])
Pituitary dysfunction | Dysfunction adrenal
Item
history of pituitary or adrenal dysfunction
boolean
C0281947 (UMLS CUI [1])
C0549609 (UMLS CUI [2])
Heart Disease
Item
clinically significant heart disease
boolean
C0018799 (UMLS CUI [1])
Cancer Other
Item
other malignancy
boolean
C1707251 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
known brain metastasis
boolean
C0220650 (UMLS CUI [1])
Gastrointestinal Disease Affecting Absorption
Item
gi disorder affecting absorption
boolean
C0017178 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
Contraceptive methods Unwilling
Item
not willing to use contraception
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
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